Tredaptive®, Pelzont®, Trevaclyn® (niacin/laropiprant): start of a review procedure in accordance with Article 20 of Regulation (EC) No. 726/2004
2013.01.02
Active substance: niacin | laropiprant
The European Medicines Agency (EMA) has initiated a review procedure regarding the lipid-lowering drugs Tredaptive®/Pelzont®/Trevaclyn® after the MAH of the medicinal products had published preliminary results of a large, long-term study.
To the risk assessment procedure (available in German only)